BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 7468914 · Received April 27, 2018

    Report

    Report Number
    2210968-2018-72387
    Event Type
    Injury
    Date Received
    April 27, 2018
    Report Date
    April 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TITLE: DOES THE SINGLE PORT ACCESS INCREASE THE MORBIDITY RELATED TO THE INCISION IN THE EARLY AND LATE POSTOPERATIVE PERIOD? AUTHORS: SOCAS-MACIAS M., MORALES-CONDE S., ALARCON DEL AGUA I., NAVAS CUELLAR A., JIMENEZ G., GARCIA J., MENDEZ C., CADET H., PADILLO RUIZ J. AND BARRANCO MORENO A. CITATION: SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES. 2014 APR; CONFERENCE: 21ST INTERNATIONAL CONGRESS OF THE EUROPEAN ASSOCIATION FOR ENDOSCOPIC SURGERY, EAES 2013. VIENNA AUSTRIA. CONFERENCE PUBLICATION: (VAR.PAGINGS). 28 (SUPPL. 1) :S5; DOI HTTPS://DOI.ORG/10.1007/S00464-014-3483-0. THE AIM OF THIS STUDY WAS TO ANALYZE THE MORBIDITY RELATED TO SINGLE-PORT ACCESS (SPA), AS WELL AS THE RISK OF DEVELOPMENT AN INCISIONAL HERNIA AFTER APPLYING A 'PROTOCOL TO CLOSE THE SPA', BASED ON PATIENT'S CHARACTERISTICS AND THE TECHNICAL DIFFICULTY OF CLOSING THE FASCIAL DEFECT. DURING THE PROCEDURE, A TRANSUMBILICAL INCISION BETWEEN 1.5-3 CM. THE AUTHORS APPLIED THE PROTOCOL TO CLOSE THE SPA FASCIAL INCISION, WITH POSTERIOR CLOSURE OF THE SKIN WITH SINGLE STITCHES OF VICRYL-RAPID 2/0. COMPLICATIONS REPORTED WERE 6 SEROMAS WHICH WAS SOLVED AFTER MEDICAL TREATMENT, AND 5 SURGICAL WOUND INFECTION WHICH NEEDED TO BE DRAINED, ALL OF THEM AFTER COLONIC SURGERY. THERE WERE ALSO 3 CASES OF INCISIONAL HERNIAS, IN PATIENTS IN WHICH A PROPHYLACTIC MESH WAS NOT USED. IN CONCLUSION, NEITHER TRANS-UMBILICAL INCISION NOR MESH PLACEMENT SEEMS TO INCREASE THE MORBIDITY RELATED WITH THE SPA IN THE EARLY POSTOPERATIVE PERIOD. A TAILORED APPROACH TO CLOSE THE FASCIAL DEFECT IN THE SPA SEEMS TO ELIMINATE THE RISK OF INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310328 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention